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Claims for Patent: 9,132,110

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Claims for Patent: 9,132,110

Title:Treatment of pain with topical diclofenac
Abstract: The field involves compositions useful for pain relief, including diclofenac solution and gel formulations, in particular methods of use thereof, articles of manufacture and kits that provide novel preclinical, clinical and other information to users.
Inventor(s): Singh; Jagat (Scarborough, CA), Shainhouse; Joseph Zev (North York, CA), Galer; Bradley S. (West Chester, PA), King-Smith; Robert Dominic (San Diego, CA), Grierson; Lisa Marie (Richmond Hill, CA), Burian; Maria (Stolberg, DE), Wilkin; Jonathan (Columbus, OH), Kisak; Edward (San Diego, CA), Newsam; John M. (La Jolla, CA)
Assignee: HZNP LIMITED (Pembroke, BM)
Application Number:13/665,790
Patent Claims: 1. A method for applying topical agents to a knee of a patient with pain, the method comprising: (a) a patient obtaining a topical diclofenac preparation; (b) the patient being informed to: i) apply a first medication consisting of the topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation comprises a therapeutically effective amount of diclofenac, or a pharmaceutically acceptable salt thereof, and 40-50% w/w dimethyl sulfoxide; ii) wait for the treated area to dry; iii) subsequently apply a sunscreen, an insect repellant or a second medication consisting of a topical medication, which is other than said first medication, to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation, and then (c) the patient carrying-out steps i-iii as informed.

2. The method according to claim 1, wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.

3. The method according to claim 1, wherein said therapeutically effective amount of diclofenac, or a pharmaceutically acceptable salt thereof, is 2% w/w diclofenac sodium.

4. The method according to claim 1, wherein said diclofenac preparation further comprises ethanol, propylene glycol, and water.

5. The method according to claim 1, wherein said diclofenac, or a pharmaceutically acceptable salt thereof, comprises a pharmaceutically acceptable salt of diclofenac selected from a sodium salt, a potassium salt, a diethylamine salt, or an epolamine salt.

6. The method according to claim 5, wherein said diclofenac, or a pharmaceutically acceptable salt thereof, comprises diclofenac sodium.

7. The method according to claim 1, wherein said second medication is an NSAID.

8. The method according to claim 1, wherein the second medication other than said first medication is a corticosteroid.

9. The method according to claim 1, wherein the signs and symptoms of osteoarthritis are treated.

10. A method for applying topical agents to a knee of a patient with pain, said method comprising: (a) providing a topical diclofenac preparation; (b) providing information to: i) apply a first medication consisting of the topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation comprises a therapeutically effective amount of diclofenac, or a pharmaceutically acceptable salt thereof, and 40-50% w/w dimethyl sulfoxide; ii) wait for the treated area to dry; iii) subsequently apply a sunscreen, an insect repellant or a second medication consisting of a topical medication, which is other than said first medication, to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation; and then (c) the patient conducting steps i-iii in accordance with published material.

11. The method according to claim 10, wherein said therapeutically effective amount of diclofenac is 2% w/w diclofenac sodium.

12. A method for applying topical agents to a knee of a patient with pain, said method comprising: (a) providing a topical diclofenac preparation to the patient (b) informing the patient to: i) apply a first medication consisting of the topical diclofenac preparation to an area of the knee of said patient to treat osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation comprises a therapeutically effective amount of diclofenac, or a pharmaceutically acceptable salt thereof, and 40-50% w/w dimethyl sulfoxide; ii) wait for the treated area to dry; iii) subsequently apply a sunscreen, an insect repellant or a second medication consisting of a topical medication, which is other than said first medication, to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation and then (c) administering the first medication to the knee conducting steps i-iii in accordance with a medium providing information.

13. The method according to claim 12, wherein said therapeutically effective amount of diclofenac is 2% w/w diclofenac sodium.

14. A method for applying topical agents to a knee of a patient with pain, the method comprising: applying a first medication consisting of the topical diclofenac preparation to an area of the knee of said patient to treat the signs and symptoms of osteoarthritis of the knee of said patient, wherein the topical diclofenac preparation comprises a therapeutically effective amount of diclofenac, or a pharmaceutically acceptable salt thereof, and 40-50% w/w dimethyl sulfoxide; waiting for the treated area to dry; and subsequently applying a second medication consisting of a topical medication, which is other than said first medication and is selected from the group consisting of an NSAID, tretinoin, minoxidil, and a corticosteroid, to said treated area after said treated area is dry, wherein said subsequent application occurs during a course of treatment of said patient with said topical diclofenac preparation, wherein applying, waiting and subsequently applying are performed in accordance with written instructions.

15. The method according to claim 14, wherein said diclofenac preparation comprises about 45.5% w/w dimethyl sulfoxide.

16. The method according to claim 14, wherein said therapeutically effective amount of diclofenac is 2% w/w diclofenac sodium.

17. The method according to claim 14, wherein said diclofenac preparation further comprises ethanol, propylene glycol, and water.

18. The method according to claim 10, wherein the second medication other than said first medication is a corticosteroid.

19. The method according to claim 10, wherein the second medication other than said first medication is an NSAID.

20. The method according to claim 12, wherein the second medication other than said first medication is a corticosteroid.

21. The method according to claim 12, wherein the second medication other than said first medication is an NSAID.

22. The method according to claim 14, wherein the second medication other than said first medication is a corticosteroid.

23. The method according to claim 14, wherein the second medication other than said first medication is an NSAID.

24. The method of claim 1, wherein the informing step is by written instruction.

25. The method of claim 24, wherein the written instruction is a product insert.

26. The method of claim 10, wherein the published material is a product insert.

27. The method of claim 12, wherein the medium to provide information is a member selected from the group consisting of a flyer, an advertisement, a product insert, printed labeling, an internet web site, an internet web page, an internet pop-up window, a radio or television broadcast, a compact disk, a DVD, a podcast, an audio recording, or other recording or electronic medium.

28. The method of claim 27, wherein the medium is a product insert.
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